Kids and GERD: Are PPIs Safe?

JUNE 06, 2014

Jeannette Y. Wick, RPh, MBA, FASCP

Studies support short-term use of proton pump inhibitors in children, but additional clinical trials are needed to determine their long-term safety.
Many children develop gastroesophageal reflux disease (GERD). Experts have concerns about any medication use in children since most drugs are not tested in pediatric populations and because children experience rapid growth periods.The use of drugs that may alter growth or cognitive development is generally avoided in children. Pediatricians and pediatric gastroenterologists are fairly comfortable using gastric acid–buffering agents, mucosal surface barriers, and gastric antisecretory agents in children. These agents act locally and are unlikely to have systemic effects when used prudently.

There has been an increase in the use of proton pump inhibitors (PPIs) to treat pediatric GERD. PPIs are highly selective and effective, and in adults, studies have shown they have few short- or long-term adverse effects. Many studies have documented their ability to heal erosive esophagitis in children and improve GERD symptoms. The studies have not, however, documented the long-term safety of PPIs or their effectiveness in other conditions.

The April 2014 online version of Drug Safety published a comprehensive review of PPI use in children. The authors discuss PPI efficacy, safety, and tolerability, restricting their coverage to pediatric GERD. They found ample data supporting short-term use of PPIs. When used briefly, PPIs are well tolerated. The most common of these drugs’ mild to moderate adverse effects in children is headache.

However, the authors indicate that emerging evidence suggests PPIs may not be as benign as previously believed. Studies have found serious side effects in some infants (eg, respiratory tract infections, diarrhea) and children aged 1 to 11 years (eg, vomiting, diarrhea, abdominal pain). Additional study is needed, using well-designed clinical trials and observational studies, to determine whether PPIs are safe for children and especially infants. These studies will need to assess the importance of these drugs’ developmental and genetic pharmacology in children with acid-related disorders.

Ms. Wick is a visiting professor at the University of Connecticut School of Pharmacy and a freelance writer from Virginia.